Phase III trial of Procrit for Anaemia in Breast Cancer fails-Janssen

Janssen has announced the presentation of data at the San Antonio Breast Cancer Symposium (SABCS) from the Phase III EPO-ANE-3010 study evaluating Epogen/Procrit (epoetin alfa) plus best supportive care (BSC) versus BSC when used to treat Anemia in patients with metastatic Breast Cancer receiving standard chemotherapy. This non-inferiority trial did not meet its primary objective, which was to rule out a 15 percent or greater increase in the risk of progression in the epoetin alfa plus BSC group compared with BSC.

The safety results of this study are consistent with the current FDA-approved label for Procrit (epoetin alfa), including the Boxed Warning. When used according to the approved label, Procrit can help patients avoid blood transfusions. The data show a numerically increased risk of adverse tumor outcomes, although not statistically significant, that is generally consistent with observations in other studies described in the current label. Since March 2007, the U.S. label has contained a Boxed Warning stating that erythropoiesis-stimulating agents (ESAs) shorten overall survival (OS) and/or increase the risk of tumor progression. In addition, since 2010, the FDA has required a Risk Evaluation and Mitigation Strategy (REMS) for ESAs.